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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device index-generating electroencephalograph software
Definition Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Product CodeOLW
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CORTICAL DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FILAND OY
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NEUROWAVE SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 3 3
2019 6 6
2020 15 15
2021 15 15
2022 27 27
2023 18 18
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 29 29
High Readings 24 24
Temperature Problem 23 23
Low Readings 12 12
Increase in Pressure 10 10
Device Damaged Prior to Use 9 9
Image Display Error/Artifact 8 8
Erratic or Intermittent Display 5 5
Appropriate Term/Code Not Available 5 5
Material Split, Cut or Torn 4 4
Failure to Power Up 4 4
Computer Software Problem 3 3
Noise, Audible 3 3
Device Alarm System 2 2
Patient Device Interaction Problem 2 2
Device Emits Odor 2 2
Use of Device Problem 2 2
Smoking 2 2
Connection Problem 2 2
Failure to Run on Battery 1 1
High Test Results 1 1
No Audible Alarm 1 1
No Apparent Adverse Event 1 1
Defective Component 1 1
Fire 1 1
Protective Measures Problem 1 1
Fitting Problem 1 1
No Audible Prompt/Feedback 1 1
Failure to Analyze Signal 1 1
Unable to Obtain Readings 1 1
Overheating of Device 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
Insufficient Information 39 39
No Consequences Or Impact To Patient 9 9
No Patient Involvement 5 5
Injury 3 3
Oversedation 2 2
No Known Impact Or Consequence To Patient 2 2
Death 1 1
No Code Available 1 1
Pressure Sores 1 1
Cardiac Arrest 1 1
Awareness during Anaesthesia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Aug-30-2018
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